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Biosimilars or biobetters? A definite answer to this question is not so easy these days and companies are choosing their own ways in this area. Although the first biosimilar versions of trastuzumab will probably be marketed in 2012, some companies decided to develop a biobetter version of this blockbuster monoclonal antibody.

Glycotype GmbH is a biopharmaceutical company founded in 2001 in Berlin, Germany. The company focuses on the optimization and humanization of therapeutically relevant sugar structures on biopharmaceuticals known as glycosylation and on the development of innovative antibodies targeting glycostructures on cell surfaces.

Biologics developed in Glycotope’s GlycoExpress™ technology of glycoengineered human cell lines receive a fully human and optimized glycosylation, leading to a largely improved activity, an elongated half-life time and/or reduced immunogenicity and hence important therapeutic benefits for a significantly increased number of patients. In addition, the GlycoExpress platform is superior in productions yields, product quality and reproducibility compared to other production platforms.

The company is now developing a biobetter trastuzumab, named TrasGEX. TrasGEX is an improved version of the marketed blockbuster monoclonal antibody Trastuzumab/Herceptin (Roche, Genentech, Chugai). Trastuzumab is targeting the HER2-receptor, commonly overexpressed in certain types of cancer.

Herceptin has been approved for the treatment of HER2 positive adjuvant and metastatic breast cancers and also HER2 positive gastric cancer.

Glycotope’s TrasGEX has been glycooptimized in GlycoExpress and as a result, TrasGEX shows a significantly improved ADCC-activity, in particular among all allotypes of the Fc?IIIa-receptor mediating the ADCC, promising a significantly better therapeutic outcome for all patients eligible for treatment with Trastuzumab. Simultaneously, the fully human nature of TrasGEX’ host cell lines avoids the common immunogenic reactions against host-derived non-human components.

TrasGEX is the 4th glycooptimized biopharmaceutical product in clinical trials of Glycotype. CetuGEX and PankoMabGEX are the two anti-cancer antibodies which are in the clinical stage. Also a glycooptimized Follicle-Stimulating Hormone FSH-GEX™ has already completed clinical phase Ia.

TrasGEX has entered clinical phase I in March 2011 and currently recruting patients in Graz and Innsbruck, Austria.

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